Medical Negligence News

BBC Suggests Hip Replacement Medical Negligence by MHRA

Posted on: February 29th, 2012 by Medical Negligence

A joint BBC/British Medical Journal investigation into metal on metal hip devices, has suggested that the UK medicines regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – may be guilty of hip replacement medical negligence.

The results of the investigation – as shown on yesterday evening´s Newsnight program – displayed a timeline of alleged incompetence, oversight and miscommunication in respect of the DePuy hip recall in the UK and the advice currently being provided to all recipients of metal on metal hip devices.

It was claimed in the Newsnight report that:-

  • No clinical trials were conducted on metal on metal hip implants before they were first introduced to the UK
  • The MHRA ignored a 2004 report published in the Journal of Bone and Joint Surgery that claimed “Caution still needs to be exercised [with metal on metal hip replacements] until longer term results are available.”
  • An advisory group, established by the MHRA to investigate the risks posed by metal-on-metal implants included two paid DePuy consultants and the product manager of another metal on metal hip replacement manufacturer – Smith & Nephew.
  • The MHRA ignored warnings from the U.S. Food and Drug Administration that high levels of chromium had been discovered in the placental blood and umbilical cords of women who had given birth after being implanted with a metal on metal hip replacement.
  • Despite the MHRA´s Committee on Safety of Devices recommending that patients should sign a consent form “acknowledging the risks associated with metal wear debris”, no alert was published to doctors or patients and no consent form ever produced.

The claims of hip replacement medical negligence were supported by an interview with an orthopaedic surgeon who stated that he was witnessing up to fifty times the normal level of chromium and cobalt in the bloodstreams of patients who required revision surgery, and the program raised the case of the DePuy Pinnacle metal on metal hip replacement system, which has not yet been recalled despite being virtually identical to the recalled DePuy ASR hip replacement systems and also introduced without any prior clinical testing.

In response to the hip replacement medical negligence claims, the Chief Executive Officer of the MHRA – Professor Sir Kent Woods – said that there were fundamental differences between the ways in which drugs and medical devices were introduced to the UK market and highlighted that the MRHA had just issued a new medical alert to 49,000 recipients of hip devices in respect of potentially faulty metal on metal hip implants.

The conclusion of the report suggested that commercialism had triumphed over patient safety as manufacturers rushed in to claim their share of a lucrative market, and that the MHRA were guilty of “regulatory failure” – effectively hip replacement medical negligence.